The present invention relates to a system for examination of breast tissue, preferably self-examination of breast tissue by transmitting ultrasonic radiation through the tissue to be examined. The examination system of the present invention can be portable and/or wearable and has the advantage of being readily adaptable for home use as well as being highly accurate.
Breast cancer is a disease that affects many women and men throughout the world. The death rate for women with breast cancer in the United States is estimated to exceed one in nine women and the death rate for un-diagnosed cases is even higher. The high mortality rates are due to the ease in which this disease can metastasize through blood vessels and lymph nodes. As with many types of cancer, it has been found that accurate and early diagnosis is important to reducing the rate of mortality among those affected. In most cases, breast self-examination and routine mammography are the principal means for detecting breast abnormalities at early stage of malignant development. However, the cost, discomfort and availability of mammography and the lack of knowledge about how to perform a proper self-examination reduce the chances that an individual will be diagnosed with breast cancer early enough to significantly increase the chances that the individual will be able to survive the disease. Through many clinical studies, it is also shown that breast cancer can be curable if it is found at its early stage when the treatment can be effective.
Thus, there is a long felt need for a simple procedure for breast tissue examination which is non-invasive, and which can be conducted accurately and in the privacy of a medical office or in the home. To this same end, there is a need for a tissue examination system which is capable of accurately detecting irregularities in tissue density so as to aid medical personnel in ascertaining whether certain tissues are cancerous, pre-cancerous, or otherwise benign.
The present invention meets the aforementioned need in that it has been surprisingly discovered that human breast tissue can be non-invasively examined to accurately determine the presence of irregularities in tissue density. This non-invasive examination can be conducted using a device that provides an ultrasonic signature of the breast tissue by transmitting ultrasonic waves from an ultrasonic transmitting transducer through the breast to an ultrasonic receiving transducer. In one embodiment, at least a portion of the device is wearable and includes a support element adapted to fit over at least a portion of a breast of the wearer. The support element includes a shell having an opening, a perimeter defined by the opening, an inner surface that faces the breast of the wearer during use and an outer surface opposed to the inner surface. The support element further includes a measurement apparatus having at least two mutually opposed ultrasound transducer arrays, the transducer arrays being disposed on at least a portion of the inner surface of the shell. Preferably, the support element also includes at least one bladder element disposed adjacent at least a portion of one of the mutually opposed ultrasound transducer arrays and/or the inner surface of the shell, the bladder configured so as to orient the wearer""s breast for examination. The wearable breast examination device also includes means for operatively connecting the two mutually opposed transducer arrays to a transducer driver, and means for holding the support element on the wearer during use.